CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006)drug
Likely dose
Sorafenib 400 mg orally twice dailyAI-extracted
Key inclusion· 5
  • ✓Women >18 years with histologically documented metastatic breast cancer
  • ✓Failed at least one prior chemotherapy regimen for metastatic disease; if ER/PgR positive, also failed adjuvant hormonal therapy
  • ✓Trastuzumab not indicated, no longer effective, or refused
  • ✓At least one measurable lesion by CT or MRI per modified WHO criteria
Key exclusion· 9
  • ✕Congestive heart failure >NYHA Class II
  • ✕Cardiac arrhythmia requiring anti-arrhythmic therapy (excluding beta blockers or digoxin)
  • ✕Active coronary artery disease or ischaemia
  • ✕Active clinically serious bacterial or fungal infections (>grade 2 NCI-CTCAE v3)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00101400
NCT00101400Phase 2Completed
CompareCT.gov

A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Subjects With Metastatic Breast Cancer.

Bayer·interventional·Posted Jan 11, 2005·Updated Dec 13, 2013

In Brief

A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) for Breast Neoplasms and Breast Cancer. Completed, enrolled 54 participants across 7 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms, Breast Cancer
CountriesGermany, Italy
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2005
Enrollment StartFeb 1, 2004
Primary CompletionJan 1, 2006
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 21.5 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006)drug

Sorafenib 400 mg administered twice daily (b.i.d.)